MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y339H
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Before use on the patient, it was reported that, it was found that something like oil stain was on next to the barcode of the box.Upon evaluation of the returned sample, it was determined that one side of the box was dirty or stained.Based on the information currently available, the cl foreign matter was identified during the investigation of the sample received.This product issue will be addressed through quality system.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Sample analysis: visual analysis of the returned sample determined that one sealed box of product code y339h was received for evaluation.According to the visual inspection of the sample received, it was determined that one side of the box was dirty or stained.Based on the information currently available, the cl foreign matter was identified during the investigation of the sample received.This product issue will be addressed through quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.,according to the information received, it was found that there was something similar to an oil stain next to the barcode on the box.Photo analysis: this is a scan of an image submitted for evaluation.During the visual analysis of the image, a sealed box with a visible stain was observed, with the product code y339h.Based on revision (b)(4), the described event appearance confirmed, however, no conclusion or root cause could be determined.See device review for full review details and conclusion.As part of ethicon endo surgery's quality process, all devices are manufactured, inspected and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: MCRYL VIO 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14684868
• Report Number: 2210968-2022-04531
• Device Sequence Number: 14657199
• Product Code: GAN
• UDI-Device Identifier: 10705031058859
• UDI-Public: 10705031058859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: Y339H
• Device Catalogue Number: Y339H
• Device Lot Number: RLMJJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown